EDAP TMS(US:EDAP)2025-05-15 13:32Financial Data and Key Metrics Changes - HIFU revenues for Q1 2025 were EUR 6.2 million, an increase of 6.8% compared to EUR 5.8 million in Q1 2024 [12][25] - Total worldwide revenue for Q1 2025 was EUR 13.6 million, a decrease of 9.1% from EUR 14.9 million in the same period in 2024 [13][26] - Gross profit for Q1 2025 was EUR 5.7 million, down from EUR 6.4 million in Q1 2024, with a gross profit margin of 42% compared to 42.8% year-over-year [26] - Net loss for Q1 2025 was EUR 7.1 million or EUR 0.19 per diluted share, compared to a net loss of EUR 4.5 million or EUR 0.12 per diluted share in the prior year [28] Business Line Data and Key Metrics Changes - The company placed nine Focal One systems in Q1 2025, a record for any first quarter, including six cash sales and three operating leases [5][8] - U.S. procedures grew approximately 4% over Q1 2024, indicating strong demand for Focal One among the U.S. urology community [13][14] - The decline in non-core revenue was expected due to the strategic decision to focus on high-growth opportunities in HIFU [13][26] Market Data and Key Metrics Changes - In international markets, four cash sales of Focal One were completed outside the U.S. in Q1 2025, indicating growing momentum [12] - Major placements included hospitals in competitive environments, such as Baylor Scott and White Health and Methodist Charleston Medical Center [9][10] Company Strategy and Development Direction - The company aims to become the global leader in HIFU focal therapy, with significant strategic decisions made to support this transformation [5] - The launch of the new Focal One I robotic HIFU system represents a significant advancement, incorporating cutting-edge technology and feedback from customers [23][33] - The company is focusing on expanding its presence in the management of prostate cancer and exploring new indications for its technology [19][33] Management's Comments on Operating Environment and Future Outlook - Management noted challenges in the payer landscape, particularly with longer review times for Medicare Advantage patients, but emphasized ongoing efforts to improve market access [14][36] - The company reiterated its 2025 revenue guidance, expecting HIFU revenue to grow between 16% and 25% year-over-year, while non-core segments are expected to decline [32][33] Other Important Information - The company received CE Mark approval for the treatment of deep infiltrating endometriosis, marking a significant regulatory milestone [15][16] - The first remote transatlantic Focal One robotic HIFU procedure was successfully conducted, showcasing technological advancements [17][19] Q&A Session Summary Question: Can you elaborate on the changing trends in the payer landscape? - Management indicated that the trends are primarily relevant to Medicare Advantage Plan patients, with ongoing efforts to work closely with payers and improve reimbursement processes [36][37] Question: Has the trend continued into Q2, and are procedures ultimately getting approved? - Management acknowledged the risk of denials but noted significant progress in appeals, with a majority of appeals being successful [39][40] Question: What are the next steps for marketing Focal One for endometriosis in Europe? - The company is working on a controlled market entry in CE Mark countries, with plans for a broader launch following initial efforts [45][46]